Apparatus to be worn and method for removing fluid from a living subject

ABSTRACT

Manifolds are disclosed for introducing fluid into the human body and removing fluid therefrom. The fluid removing manifolds include a plurality of separately valved containers sealed to the manifold. Each container is filled in series via the manifold and the associated valve is closed before the container is removed from the manifold for disposal. Thus, a closed drainage system is provided. The fluid introducing manifolds include a plurality of separately valved input ports. Preferably, each port is used only once to reduce contamination of the manifold and associated infection. In each case, the port is kept closed until it is coupled to a source of fluid, and it is reclosed before the source of fluid is disconnected from the port. In this way, contamination is further reduced. Both the multiple input port feature and the multiple container feature of the invention are incorporated in manifolds for use with peritoneal dialysis.

This application is a continuation of application Ser. No. 045,294,filed June 4, 1979, now abandoned.

BACKGROUND OF THE INVENTION

The present invention is directed to improved devices and methods forreducing infection associated with the collection of body fluid from ahuman or animal subject and the introduction of fluids into the body.

In modern medical practice it is often desirable either to drain fluidsfrom or to introduce fluids into a human or animal subject under sterileconditions. For example, it is a routine practice to catheterizehospital patients for urinary or closed wound drainage. Similarly, anumber of body cavities, such as the urinary bladder and the peritonealcavity, for example, are routinely irrigated during treatment of variousdisorders. In these and other, similar situations the continuedsterility of all associated devices used for passing fluid to and fromthe body may be critically important, for a contaminated device will inmany cases lead to infection of the patient.

It is well recognized that conventional drainage devices are a primesource of infection in catheterized patients. For example, in the areaof bladder drainage, a large proportion of catheterized patients sufferfrom urinary tract infections attributable to contaminated drainagedevices. In many cases, the drainage collection device itself becomescontaminated in use and infection then ascends in a retrograde mannerfrom the drainage collection device to the patient via the drainagecatheter. Such retrograde infection from a contaminated drainage orinfusion device has been observed in patients undergoing urinary, wound,biliary, gastro-intestinal drainage, peritoneal dialysis, andhyperalimentation treatment for example. See, e.g., E. M. Goldberg, etal., "Peritoneal Dialysis", Dialysis and Transplantation, June/July1975, Vol. 4 #4; J. H. Isaccs, et al., "Foley Catheter Drainage Systemsand Bladder Damage", Surgery, Gynecology & Obstetrics, May 1971, p. 889;R. E. Desautels, "The Causes of Catheter-Induced Urinary Infections andTheir Prevention", J. Urology, 1969, 101: 757; R. E. Desautels, et al.,"Technical Advances in the Prevention of Urinary Tract Infection", J.Urology, 1962, 87: 487; R. E. Desautels, "Aseptic Management of CatheterDrainage", New Eng. J. Med., 1960, 263: 189; E. H. Kass, et al.,"Prevention of Infection of Urinary Tract in Presence of IndwellingCatheters", J.A.M.A., 1959, 169: 1181; and E. H. Kass, et al., "Entry ofBacteria into the Urinary Tracts of Patients with Inlying Catheters" NewEng. J. Med., 1957, 256: 556.

Retrograde infection via drainage devices is in many cases attributableto the fact that conventional drainage devices are open systems whichare repeatedly opened to the atmosphere and, therefore, subject tocontamination during use.

Many conventional drainage devices are containers designed to be filledrepeatedly with drained body fluid and emptied. For example, theevacuator described by McElhenny in U.S. Pat. No. 3,115,138 includes acapped fluid outlet. After the evacuator becomes filled it is emptiedfor reuse by removing the cap and expelling collected fluid via theoutlet. During this operation the interior of the evacuator is exposedto the atmosphere and contamination of the evacuator may result.

Efforts have been made to reduce the contamination of drainage devicesduring periodic emptying. For example, U.S. Pat. Nos. 3,779,243 and3,774,611 disclose evacuators which employ a special valve over thefluid outlet. This valve operates to close the outlet at all timesexcept for the time when fluid is actually being purged from theevacuator. Such evacuators may succeed in reducing the contaminationbrought on by purging, but they are not true closed systems. Becausethese evacuators are periodically opened for purging, it is stillpossible for them to become contaminated and a source of infection.

One object of the present invention is to provide improved drainagedevices and methods for reducing the incidence of retrograde infectiondue to contamination of drainage devices.

In addition to infection due to contamination of drainage devices, asecond source of patient infection is contamination of devices forintroducing fluid into the body. For example, in peritoneal dialysislarge volumes of a dialysate are introduced into and then drained fromthe peritoneal cavity daily. One conventional approach to this mode oftreatment is to use a permanent indwelling catheter and then simply toconnect the catheter successively to a series of containers, each ofwhich contains a portion of the total fluid introduced into the body.

In this approach the indwelling catheter is connected to and thendisconnected from a number of containers in sequence. The sameconnection point on the catheter is repeatedly brought into contact withthe dialysate and then exposed to the atmosphere. This repeated wettingand exposure to atmosphere is believed to contribute to contamination ofthe catheter and associated infection. In much the same way, devices forirrigating body cavities such as the bladder may become infected as theyare connected to and then disconnected from a number of containers ofirrigation fluid in succession.

Thus, a second important object of the present invention is to provideimproved devices and methods for introducing fluid into human and animalsubjects with reduced possibilities of contamination thereby improvingsterility and reducing infection.

SUMMARY OF THE INVENTION

The present invention is directed to improved devices and methods fordrawing fluid from and introducing fluid into a human or animal subject,which are less susceptible to contamination and infection than devicesand methods of the prior art.

According to a first feature of this invention, a completely closeddrainage device is provided in which the interior of the device neednever be opened to atmosphere during use. This invention is suitable forwidespread use in many types of drainage, and can be used in conjunctionwith either suction or gravity drainage treatment.

The drainage device of this invention includes a central manifoldadapted for connection to a source of body fluid. For example, themanifold may be connected to a drainage catheter which is conventionallylocated to drain urine from the bladder of a human subject. A pluralityof containers are separately connected to the manifold by conduits, andindividual conduits are provided with valves which can be positioned toclose off the conduits, thereby isolating the associated containers fromthe manifold. Each of the conduits is severable at a point between theassociated valve and container.

In use, this improved drainage device is coupled to a subject so thatfluid flows from the patient into the manifold. The valves arepositioned to direct the fluid into one of the containers, and fluid isallowed to collect in this container for a period of time. Theassociated valve is then closed in order to isolate this fluid filledcontainer from the manifold, and the associated conduit is severedbetween the container and the valve. The fluid filled container is thenremoved for testing or disposal, and another valve is opened to allowfluid to collect in another container. The separate containers aresequentially filled and removed until either all containers are filledor drainage from the subject is discontinued.

One of the principal advantages of this improved drainage device andmethod is that each of the multiple containers can be filled and removedfrom the manifold without ever opening the device to atmosphere duringuse. When drainage begins the entire device, complete with a number ofcontainers already attached to the manifold, is a sealed, sterile unit.Containers are sequentially filled and removed, but the removal ofindividual containers is performed only after the respective valve hasbeen closed and the container isolated. Preferably, each valve is cappedto further seal it from the environment after the associated containerhas been removed. In this way contamination of the manifold andresultant infection of the subject are reduced.

Since the drained body fluid is removed in a series of containers ofconvenient size, the volume of fluid stored in the drainage device atany one time can be kept small in spite of the large total volume of thedrainage device. Thus, the patient is not required to carry the totalvolume of drained fluid. The portability and the convenience of theimproved drainage device of this invention provide important advantagesover large capacity drainage devices of conventional design.

Furthermore, each of the individual containers can be made of acollapsible material which can be folded into a compact volume forstorage before use. In this way a compact drainage device can be madewhich is readily stored and transported before use, and is relativelylow in bulk during use.

This feature of the invention can be advantageously used in urinarydrainage, wound drainage, and peritoneal dialysis. It is also wellsuited for removing other fluids from the body in cases where a lowincidence of contamination or infection is important.

According to a second feature of this invention, an improved device forintroducing fluid into the human body is provided. This device includesa central manifold adapted for connection with means for introducingfluid into the body, such as a catheter. The manifold includes aplurality of valved input ports. Each port is provided with a separatevalve by means of which the port may be isolated from the manifold. Eachport is preferably provided with a cap for sealing the port when not inuse.

This device is used with a plurality of containers, each of whichcontains fluid to be introduced into the body. Preferably each containeris provided with a dry, sterile catheter and each capped input port isalso dry and sterile. To connect the container to the manifold the capis removed from one of the input ports and then the container catheteris mated to the port. After the catheter is connected, the associatedvalve is opened and fluid is allowed to flow from the container, throughthe port, into the manifold, and from there into the body. When thecontainer is emptied, a second container is then connected to themanifold via a second port. In each case the associated port valve isonly opened after the container has been connected to the port and thevalve is closed before the container is removed. Preferably, each portis only used once so that a fresh, sterile surface on a fresh port ismated to the container each time. By never using a port twice it isbelieved that the incidence of contamination and infection is reduced.

This second feature of the invention can be advantageously used inirrigation of the bladder, peritoneal dialysis and hyperalimentationtreatment, as well as in other modes of treatment in which fluid fromseveral containers must be introduced into the body over a period oftime.

Both of the above described features of the invention can be utilized ina dialysis manifold for use in peritoneal dialysis. In this case acentral manifold can be provided both with (1) a number of containersconnected to the manifold via valved conduits and (2) a number of valvedinput ports. The dialysis manifold is coupled to the peritoneal cavityof a subject and the separate containers are used as previouslydescribed to remove dialysate from the manifold without opening it tothe atmosphere. The input ports are also used as described above,thereby reducing infection associated with the introduction of dialysateinto the manifold.

Alternately, a manifold for peritoneal dialysis may be constructed withonly a plurality of valved ports and the attached containers may beomitted. In this embodiment of the invention containers of dialysate aresequentially coupled to different ports. As before, each port is usedonly once to reduce infection. In this embodiment, however, a dialysatecontainer is not immediately removed from the associated port after thedialysate has been drained into the peritoneal cavity. Instead, thecontainer is left connected to the port and the dialysate is thendrained from the peritoneal cavity into the same container from which itcame. It is only then that the container is removed from the port. Thisembodiment provides the important advantage that the total drainagecapacity of the manifold is no longer limited by the number ofcontainers that can conveniently be stored adjacent the manifold.

The invention itself, together with further objects and attendantadvantages, will be best understood by reference to the followingdescription taken in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a preferred embodiment of a rack mounteddrainage manifold for urinary drainage.

FIG. 2 is a cross sectional view of the drainage manifold of FIG. 1.

FIG. 3 is a perspective view of a portable drainage manifold for urinarydrainage.

FIG. 4 is a schematic view of a drainage manifold coupled to a closedwound suction device.

FIG. 5 is a perspective view of a preferred embodiment of an inputmanifold for wound or bladder irrigation.

FIG. 6 is a perspective view of a first preferred embodiment of aperitoneal dialysis manifold which includes preferred embodiments ofboth the closed drainage feature and the multiple input port feature ofthe present invention.

FIG. 7 is a top view taken along line 7--7 of FIG. 6.

FIG. 7a is a cross sectional view taken along line 7a--7a of FIG. 7.

FIG. 7b is a cross sectional view taken along line 7b--7b of FIG. 7.

FIG. 8 is a bottom view taken along line 8--8 of FIG. 6.

FIG. 8a is a cross sectional view taken along line 8a--8a of FIG. 8.

FIG. 9 is a cross sectional view taken along line 9--9 of FIG. 6.

FIG. 10 is a perspective view of a portion of a second preferredembodiment of a peritoneal dialysis manifold.

FIG. 11 is a cross sectional view taken along line 11--11 of FIG. 10.

FIG. 12 is a perspective view of a third preferred embodiment of aperitoneal dialysis manifold.

FIG. 13 is a cross sectional view taken along line 13--13 of FIG. 12.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to the drawings, FIG. 1 represents a preferred embodimentof a drainage manifold 10 for urinary drainage. This drainage manifold10 is a generally tubular structure which is provided with a valvedinput port 50 and four valved output ports 30. A collapsible, thinwalled container 20 is sealed to each of the output ports 30. In FIG. 1,three of these containers 20 are shown collapsed and folded for storageinto small packets and one of the containers 20a is shown unfolded,ready to receive fluid from the manifold 10. Preferably, each containeris formed of a flexible, plastic material such as vinyl, polyethelene,or some other suitable material. A support net 90 is provided which canbe positioned around an unfolded container 20a by means of a hook 92from the manifold 10. This net 90 serves to support a major part of theweight of fluid contained in the container 20a, thereby permitting theuse of thin, low bulk material for the containers 20.

The valved input port 50 is adapted for connection to a catheter 62which is in turn coupled to a source of body fluid. In this exemplaryembodiment, the manifold 10 is a urinary drainage device and thecatheter 62 can be any suitable urinary drainage catheter. A snap-on cap70 is provided adjacent the input port 50 to cover and protect the inputport 50 prior to use. Anchor points 74 serve as means for attaching themanifold 10 to any conventional mount such as a rack 76.

Referring now to FIG. 2, the manifold 10 is a tubular structure whichdefines a central cavity 100. Both ends of the manifold 10 are sealed toprevent leakage and contamination. The input port 50 includes a valve 60which operates to selectively seal the port 50. The valve 60 is providedwith a flange 52 sealed to the manifold 10 and the port 50 extends intothe interior of the manifold 10. The cap 70 is attached to the inputport 50 via a flexible strap 72.

Each of the valved output ports 30 includes a valve 40 which operates toselectively seal the port 30. Each valve 40 includes a flange 32 sealedto the manifold 10 and each output port 30 extends into the interior ofthe manifold 10. Each container 20 includes a narrow neck region 24which is sealed to one of the input ports 30.

The manifold is preferably formed from an extruded tube of vinyl or someother suitable plastic. Standard push-pull valves, such as valve model320TE manufactured by Halkey-Roberts of Paramus, N.J., are used toreliably seal the associated input ports 50 and output ports 30 againstcontamination, leakage, and infection. The entire device, including themanifold 10, the foldable containers 20 and the input port 50, forms asingle sealed unit which is assembled under standard clean roomconditions and then sterilized prior to use. Standard adhesive or heatsealing techniques can be used to bond the manifold 10, the containers20, and the ports 30,50 together to form a sealed, leakproof unit.Whatever sealing technique is used, however, should provide reliable,leakproof seals which form impermeable barriers to contamination andinfection. After assembly, the single opening into the manifold 10 isthe valved input port 50, which is closed and capped during themanufacturing process to ensure the continued sterility of the device.

In use, the drainage device of FIGS. 1 and 2 functions as a closedsystem which receives fluid drained from the body and permits thedrained fluid to be removed for disposal without ever opening thedrainage device to contamination. As mentioned, the device is originallysterilized with the input port 50 closed and capped. To use thisdrainage device the input port 50 is uncapped and mated with a suitablecatheter under sterile conditions. Depending on the application, thiscan be done either before or after the catheter has been inserted intothe patient. In alternate embodiments, the drainage catheter can besealed to the input port 50 during the manufacturing process and theentire assembly, including the catheter, can be sterilized as a unit.

After the input port 50 has been mated to the catheter 62 and thecatheter 62 has been inserted into the body, the input port valve 60 isopened, one of the containers 20 is unfolded, and the output port valve40 associated with that container 20 is opened. Fluid then drains fromthe body, through the catheter, into the manifold 10, and from thereinto the selected container 20. When this container 20 is filled, theassociated valve 40 is closed, and then the filled container is severedfrom the associated valve 40 and discarded. A second container 20 isthen unfolded, the associated valve 40 is opened, and drainage thencontinues into this second container 20.

Each of the containers 20 is preferably filled in sequence so that nomore than one container is receiving drained fluid at any given time. Ineach case the associated valve 40 is closed before a container 20 issevered, and thus the manifold is never opened to atmosphere orcontamination after it has been connected to the source of body fluid.Large quantities of fluid can be drained over an extended period of timewithout ever opening the system to atmosphere.

The closed system drainage device of this invention has widespreadapplication to a host of situations in which prolonged or large volumedrainage is required and a low incidence of infection is important. Byway of example, this drainage system can be used in urinary drainage,wound drainage (either with or without wound suction devices), drainageof ascites, drainage of pleural effusion, choledochostomy and T-tubedrainage, and pyelo-nephrostomy to drain kidneys. Of course the numberand capacity of containers 20 is entirely a matter of choice whichshould be chosen for the particular application. The embodiment of FIG.1 is provided with four two-liter bags by way of example, for in urinarydrainage the average duration of treatment is less than four days andthe average daily urine production is less than two liters. Thus, thisembodiment provides a simple, closed system drainage device withadequate capacity for the average case. In situations where drainage ischronic and the avoidance of infection crucial, as in the treatment ofsome paraplegics, for example, it is preferable to use a closed systemdrainage device with much larger drainage capacity.

Turning now to FIG. 3, the closed system drainage device of thisinvention is well suited for use with ambulatory patients. FIG. 3 showsa portable urinary drainage device which is generally similar to that ofFIGS. 1-2. As before, a central manifold 10' is provided with a valvedinput port 50' and four valved output ports 30', each of which isconnected to a collapsible container 20'. The input port 50' is adaptedfor connection with a urinary drainage catheter 62', and the entireassembly, including the manifold 10', the containers 20' and the inputport 50', is manufactured as a single sealed unit which is sterilizedprior to use.

In this case the two ends 12',14' of the manifold 10' are provided withmating hook-and-loop fasteners such as those marketed under the trademark "Velcro", and the manifold 10' is sized to fit around the thigh ofa patient at a point below the bladder. The weight of the manifold 10'and any suspended containers 20' is supported by straps 16' whichconnect the manifold 10' to a belt 18' sized to fit around the waist ofthe patient.

Preferably, each of the output ports 30' is at least 1/2 inch long, asshown, to permit the port 30' to bend as necessary without closing offas the patient bends his knee in walking and sitting. If desired, eachcontainer 20' may be provided with a line 22' at its lower end to holdthe containers securely to the leg of the patient. The method of use andthe internal structural details of this embodiment are similar to thoseof FIGS. 1-2.

FIG. 4 shows a schematic view of a closed system drainage device of thisinvention arranged to receive drainage material from a closed woundsuction device 150. Once again, the drainage device includes a manifold10", a valved input port 50", and several containers 20" connected tothe manifold 10" by valved output ports 30". In this application, thedrainage device is connected to a suction device 150 via a conduit 152,and the suction device 150 is connected to the body of the patient via aconduit 154.

The suction device 150 can be a conventional closed wound suctiondevice, and it is operated in the conventional manner except that thesuction device 150 is periodically emptied through the manifold 10" intoone of the attached containers 20" without ever opening either thesuction device 150 or the manifold 10" to atmosphere. As before, theclosed system drainage device operates to reduce contamination andresulting retrograde infection of the patient.

It should be apparent from the foregoing discussion that the closedsystem drainage device of this invention can be used either with orwithout suction devices in either fixed installation or portableembodiments. In alternate embodiments of the invention the manifold canbe adapted for particular applications. The manifold can be integratedwith a suction device if desired and it can be made in the shape andwith the degree of rigidity or flexibility best suited for theparticular application.

As previously mentioned, the present invention also includes devices andmethods for introducing fluid into the body from multiple sources. Ingeneral, these devices include multiple separately valved input ports,each of which is preferably used only once. These devices and methodsare well suited for bladder irrigation, wound irrigation, and othersituations where sterile fluids are introduced into the body.

Turning now to FIG. 5, a preferred embodiment of the multiple inputdevice of the invention includes an irrigation manifold 130 which may beconstructed similarly to the manifold 10 of FIG. 1. This manifold 130 isprovided with a single output port 132 adapted for connection with asuitable catheter. This output port 132 is provided with a check valve134, oriented to prevent fluid from entering the manifold 130 via theoutput port 132, and a valve 136, which operates to selectively closethe output port 132.

The manifold 130 is also provided with a plurality of input ports 140,each of which includes a valve 150 and a snap-on cap 160. Anchor points138 are included on the manifold 130 to facilitate mounting the manifold130 to a support structure such as a rack 180.

This irrigation manifold is manufactured under standard clean roomconditions. The output port 132 is then closed by means of the valve 136and capped, each of the input ports 140 is capped and closed by means ofthe associated valve 150, and then the entire sealed manifold assemblyis sterilized.

In use, the output port 132 is coupled to an irrigation catheter, suchas a bladder irrigation catheter, for example. As before, the cathetercan be made an integral part of the output port 132, or the port 132 canbe mated with a suitable catheter either before or after the catheterhas been inserted into the body. A container of irrigating solution isthen connected to one of the input ports 140 and the associated valve150 is opened to allow the solution to pass into the manifold 130 andout the output port 132 into the body.

When a second container of nutrient is needed, the valve 150 on theinput port 140 connected to the first container is closed and the firstcontainer is removed. Then the second container is coupled to a freshinput port 140 that has not previously been used and the process isrepeated. Each input port is preferably used only once to reduce theincidence of infection. Of course, normal precautions should be taken toensure that containers of solution are connected to the input ports 140under dry, sterile conditions.

The multiple input port feature of the invention is not restricted touse in irrigation. It can be used in many situations where fluid frommultiple sources must be introduced into the body under sterileconditions. For example, it may be used in intravenous administration ofnutrients and medicines and in hyperalimentation treatment. In eachapplication the size of the manifold and the size and number of theinput and output ports should be chosen to fit the intended use. Onealternate embodiment of the irrigation manifold 130 of FIG. 5 includes asmall, tubelike manifold which attaches directly to the irrigationcatheter and includes a small number of valved input ports. In thisembodiment, the output port is nothing more than the junction betweenthe manifold and the catheter, and the output port valve can beeliminated. This alternate embodiment is well suited both for collectingsamples of body fluid as well as introducing fluid into the body.

Referring now to FIG. 6, both the multiple valve container feature ofthe invention and the multiple valved input port feature of theinvention can be used together in a manifold for peritoneal dialysis.FIG. 6 represents a first preferred embodiment of such a dialysismanifold.

The dialysis manifold of FIG. 6 includes a belt 210 sized to fit aroundthe abdomen of a patient. This belt 210 is a tubular structure whichdefines a central manifold, as will be shown in greater detail in laterfigures. The belt 210 is preferably extruded from a flexible plasticmaterial such as vinyl and should have adequate rigidity to prevent thetube of the belt 210 from collapsing during normal use.

A strip of cloth 214 is bonded to the interior surface of the belt, byheat sealing or adhesive bonding, for example. In use, the belt 210 isworn next to the body, and the cloth strip 214 acts to reduce lateralslippage and chafing of the belt against the body.

Four fasteners 212 are secured at spaced intervals to the outsideperimeter of the belt 210. In actual use, a lightweight fabric vest 280is secured to the belt 210 by vest fasteners 282 which couple with thebelt fasteners 212. Hook and loop fasteners are preferably used for bothsets of fasteners 212 and 282 in this preferred embodiment. Suchfasteners are commonly available under the trade mark "Velcro". The vest280 serves to support the weight of the belt 210 on the shoulders of thewearer, and it improves the comfort and wearability of the belt 210. Inalternate embodiments, suspenders can be substituted for the vest 280;however, for many applications, the vest 280 provides improved long-termwearing comfort as compared with suspenders.

The belt 210 is a single tubular structure which is flattened at the endsections 216,218. Both end sections 216,218 are provided with matingfasteners, such as hook and loop fastener strips. These fasteners act tosecure the two ends of the belt together and to hold the belt in placearound the abdomen of the wearer. Hook and loop fasteners provide theadvantage of adjustability.

A set of eight containers 220 is mounted on each side of the bottomportion of the belt 210 by means of conduits 230 equipped with valves240. These containers 220 are preferably thin plastic bags formed fromvinyl or polyethelene, for example, which can be compactly folded asshown in FIG. 6 prior to use. Each bag is sealed to the lower end of theassociated valve 240 which is in turn sealed to a conduit 230 extendingfrom the belt 210. Adhesives or heat sealing techniques may be used tosecure the containers 220, the valves 240, the conduits 230, and thebelt 210 to form a single sealed, leakproof unit which provides animpermeable barrier to contamination and infection.

Each of the containers 220 is originally folded into a small packetadjacent the associated valve 240. The use of these containers will beexplained in detail below. Here it is enough to note that each containercan be unfolded to its full size as shown by the unfolded container220a. Each container may be of any desired capacity. In the presentlypreferred embodiment the containers 220 have a capacity of two litersand each container 220 is provided with a volumetric scale 222 by meansof which the volume of fluid contained in the container may beestimated.

A support net 290 is secured by means of two hooks 292 to the belt 210and placed around a container 220a as it is filled. This net bag 290serves to support a major part of the weight of the fluid in thecontainer 220a, and in this way reduces the strain on the container 220aand the associated valve 240 and conduit 230.

A set of eight input ports 250 is mounted on each side of the top of thebelt 210. Each port 250 is a tubular structure which is provided with avalve 260 and a snap-on cap 270. Once again, the ports 250, valves 260,and belt 210 are bonded together to form a single sealed unit whichforms an impermeable barrier to infection.

Turning now to FIGS. 7-8, further features of the belt 210 will beexplained. FIG. 7 shows a top view of the rear portion of the belt 210in which the flattened end sections 216,218 and the hook and loopfasteners 213 can be clearly seen. As best shown in FIG. 7a, the belt210 is a hollow, tubular structure which defines a central volume 300.This central volume is in fluid communication with each of the inletports 250 and each of the conduits 230.

FIG. 7b shows a cross section of the belt 210 in the flattened endsection 218. In this region the tubular belt 210 has been flattened andtwo opposed sides of the belt have been sealed together to preventleakage from or contamination of the belt 210 via the end sections216,218.

FIG. 8 represents a bottom view of the front portion of the belt 210 inpartial cross section. A recess 310 is formed in the lower inside of thefront of the belt 210 to house the catheters which couple the belt 210to the subject. A belt catheter 320 passes through an opening 312 in thebelt 210 and is bonded to the belt 210 via a flange 322. Once again, itis important that a leakproof seal be formed to prevent contamination orinfection, and heat sealing or adhesive bonding techniques may be used.

The belt catheter 320 is coupled to an indwelling catheter 330 which haspreviously been inserted into the peritoneal cavity of the subject understerile conditions. The connection between the belt catheter 320 and theindwelling catheter 330 can be made in any suitable manner, as forexample with a female-to-female catheter connector 332.

The recess 310 is sized to receive both the belt catheter 320 and theindwelling catheter 330 when the belt 210 is in place around thepatient, as shown in FIGS. 8 and 8a. In this way pressure on the abdomenand attendant discomfort are reduced.

FIG. 9 shows a cross sectional view of the belt 210 showing the internalarrangement of the ports 250 and the container conduits 230. Eachconduit 230 penetrates and is in fluid communication with the centralvolume 300 and is provided with an exterior flange 232 which is sealedagainst the outside of the belt 210. In order to increase the packingdensity, adjacent conduits 230 are staggered by about 20°. This permitsthe folded containers 220 to overlap, as best seen in FIG. 6. Eachcontainer 220 defines a narrow neck region 224 which is sealed to thelower portion of the associated valve 240.

Each of the valves 240 is an on-off valve which completely seals off theinterior of the belt 210 from infection when the valve 240 is closed. Inthe presently preferred embodiment, low bulk, push-pull valves are usedin which the valve is pulled to open and pushed to close. Such valvesare readily available as standard components. Valve model 320TE,manufactured by Halkey-Roberts of Paramus, New Jersey, is one example ofsuch a valve.

Each of the ports 250 also is in fluid communication with the centralvolume 300 and is sealed to the exterior of the belt 210 via a flange252 on the port 250. The port valves 260 are preferably push-pullvalves, similar to the container valves 240. The snap-on cap 270 on eachvalve 260 serves to shield and protect the valve 260 from contaminationprior to use. Preferably, each cap 270 is secured to the associatedvalve 260 by a thin flexible strap 272. The belt 210 should be assembledin a clean room and then sterilized prior to use, utilizing standardmanufacturing practices for medical devices as outlined by the Food andDrug Administration. It should be understood that when the belt 210,containers 220, and ports 250 are assembled, all valves 240,260 areclosed, and the belt catheter 320 is sealed, prior to sterilization. Inthis way, the belt is delivered as a single, sterile unit, ready foruse.

In use, the belt 210 acts as a manifold through which dialysate can beintroduced into and removed from the peritoneal cavity with reducedincidence of infection. The first step in using this belt assembly is toconnect the belt catheter 320 to the indwelling catheter 330 of apatient under surgically sterile conditions. This step will usually beperformed in the office of the physician or in a hospital.

The next step is the introduction of dialysate into the peritonealcavity of the patient via the belt 210. First a container of dialysate(not shown) is coupled via a tube to one of the valves 260. The valve260 will be dry and sterile, for it has been capped since its initialsterilization. The dialysate tube (not shown) should also be dry andsterile. After the dialysate container has been coupled to the valve260, the valve 260 is opened, and dialysate is allowed to drain via thevalve 260 and the port 250 into the central volume 300 of the belt 210.From there, the dialysate passes via the belt catheter 320 and theindwelling catheter 330 into the peritoneal cavity of the subject. Afterthe dialysate container has been emptied, the associated valve 260 isclosed, the container is removed, and the cap 270 is replaced. In thisway the port 250 is closed by the valve 260 before it is exposed toatmosphere, thereby reducing contamination and infection.

The dialysate is allowed to remain in the peritoneal cavity for a periodof time and is then drained from the peritoneal cavity via the belt 210into one of the containers 220. Prior to this, a selected container isunfolded and placed within the support net 290. The associated valve 240is then opened and dialysate flows from the central volume 300, via theconduit 230 and the valve 240 into the container 220. After thecontainer is filled, the associated valve 240 is then closed and thefilled container 220 is removed from the belt 210 by severing the neckof the bag 220 below the valve 240. The severed container 220 and itscontents are then discarded.

Because the container 220 is not removed until after the associatedvalve 240 has been closed, the belt 210 is never opened to atmosphereduring drainage. Instead, the central volume 300 remains closed anduncontaminated.

The next batch of dialysate to be used is then connected to a secondinlet port valve 260, one which has not previously been used, and theentire procedure is repeated. In each case a fresh input port 250 and afresh container 220 are used. Because no input port 250 is used twice,it is always a dry, sterile input port valve 260 which is mated with thedialysate container. When proper precautions are taken to ensure thateach dialysate container is sterile, this use of each input port only isbelieved to reduce the incidence of infection. Furthermore, since allthe drainage containers 220 are sealed in place from the beginning,dialysate drainage is accomplished without ever opening the belt 210 toatmosphere. In this way, infection associated with drainage is reduced.

The belt 210 has been designed to minimize infection of the subject fromdialysate contamination either when introduced into the subject or whendrained. This belt is simple to use and easily portable, and it isanticipated that it will be useful in the treatment of ambulatorypatients who are not hospitalized. The patient can administer and drainthe dialysate himself, without assistance from medical personnel. Onlyafter each of the ports and containers has been used will the belt bereplaced with a new belt, complete with a new set of sterile ports andfolded containers.

One current regimen of peritoneal dialysis involves introducing anddraining two liter batches of dialysate, four times a day. The belt 210shown in FIGS. 6-9 is well suited for this regimen, in that it includes16 ports 250 and 16 two-liter containers 220. This belt 210 can be usedfor four complete days of dialysis before it will have to be replaced.

FIGS. 10 and 11 represent a second preferred embodiment of the dialysisbelt of this invention. This embodiment is similar to that of FIGS. 6-9in that it includes 16 valved inlet ports 250 and 16 valved containers220. For ease of reference, like components of the two embodiments areprovided with like reference numbers.

As best shown in FIG. 11, the belt 340 is divided by an internalpartition 342 which divides the interior of the belt 340 into twomanifolds, or chambers 350,360 which extend the length of the belt 340.The 16 inlet ports 250 all communicate with the inner chamber 360 andthe 16 valved containers 220 all communicate with the outer chamber 350via the valves 240. As shown in FIG. 10, the indwelling catheter 330 isconnected to a three-way valve 370 which is in turn coupled both to theinner chamber 360 via an inner belt catheter 334 and to the outerchamber 350 via an outer belt catheter 336. The three-way valve 370 is astandard valve which can be set to a first position to couple the innerbelt catheter 334 with the indwelling catheter 330, and to a secondportion to couple the outer belt catheter 336 to the indwelling catheter330. The three-way valve 370 can also be set to close off the indwellingcatheter when desired.

The embodiment of FIGS. 10 and 11 is used in much the same manner asthat of FIGS. 6-9, except that for introducing dialysate into theperitoneal cavity the three-way valve 370 is set in the first position,which couples the inner belt catheter 334 to the indwelling catheter330; for draining dialysate valve 370 is set in the second position,which couples the outer belt catheter 336 to the indwelling catheter330.

A principal advantage of this embodiment is that fresh dialysate is notmixed with previously drained dialysate in the belt 340. In someapplications, this may reduce the tendency for compounds leached fromthe inner walls of the belt 340 by drained dialysate from beingintroduced into the patient.

A third preferred embodiment of the dialysis belt of this invention isshown in FIGS. 12 and 13. In this embodiment, the belt 380 defines onlya single internal volume. The belt is provided with 28 valvedinput/output ports 250 arranged along the underside of the belt 380.There are no attached containers in this embodiment. Each of the ports250 is provided with a valve 260 and a snap-on cap 270 as before, andthe belt 380 includes a belt catheter (not shown) similar to thatdescribed above in connection with the FIGS. 6-9.

This belt 380 is designed to utilize the dialysate container (not shown)as a drainage container. As before, the belt 380 is originally a sealedsterile unit in which all 28 of the valves 260 are closed. After thebelt catheter is coupled to the indwelling catheter (not shown in thisview), dialysate is introduced into the belt from a dialysate containerwhich is coupled to one of the input/output ports 250 under sterileconditions. As before, each port 250 is only used once, and each valve260 is kept closed until after the dialysate container has beenconnected.

In this case, however, the dialysate container is not removed from theport 250 after the dialysate has been drained into the peritonealcavity. Instead, the dialysate container is left connected to the port250 until it is time to drain the dialysate from the peritoneal cavity.Then, without ever removing the dialysate container, the used dialysateis drained into the same container from which it came. After the useddialysate has been returned to its container the associated valve 260closed and only then is the filled dialysate container removed from theport 250.

This embodiment provides the inmportant advantages of low bulk and lowcost. In that containers need not be sealed to the belt 380 prior touse, more ports 250 can be easily placed around the belt 380. Variousnumbers of ports may be supplied, depending on the application. The 28ports of this third preferred embodiment will support a full week ofperitoneal dialysis in which four batches of dialysate are introducedand drained daily.

Of course, it should be understood that various changes andmodifications to the preferred embodiments described herein will beapparent to those skilled in the art. For example, each of the manifoldscan readily be made larger or smaller, or with different fabricationtechniques, as required. The size and number of attached containers andinput ports can be readily varied to meet the anticipated need, as canthe size and type of valves used. Moreover, each form of the inventionmay be embodied in either portable or nonportable devices, for use witheither ambulatory or bedridden patients. Such changes and modificationscan be made without departing from the spirit and scope of the presentinvention and without diminishing its attendant advantages. It is,therefore, intended that such changes and modifications be covered bythe following claims.

We claim:
 1. A method for collecting body liquids comprising the stepsof:(a) connecting a sterile, liquid receiving, device to a source ofdraining body liquids, said device including a manifold means forconnection to the source of draining body liquids and a plurality ofsterile containers connected to and below said manifold, each of saidcontainers having a valve associated therewith which is selectivelymanually operable to either open gravity flow of liquids from themanifold to the container or to isolate the container from the manifold;(b) positioning the valves to cause the body liquids to flow by gravityfrom the manifold into a preselected container; (c) repositioning thevalves to isolate said preselected container from the manifold; (d)removing said preselected container with liquids therein from themanifold so as to leave the associated valve coupled to the manifold,thereby separating the preselected container and the body liquidscontained therein from the manifold without opening the manifold duringsaid transfer of liquids to atmosphere or contamination; and (e)repeating steps (b) through (d) with a second preselected containerincluded in the drainage receiving device.
 2. In a manifold device forholding and transferring liquid that is to be moved out of a body cavityof a subject in a manner so as to maintain sterility, to reducecontamination of the liquid transferred, and to reduce incidence ofretrograde, or air-borne, infection of the subject; the improvementcomprising in combination;a chamber means with spaced upper and lowerwalls that are interconnected by side walls to define an air tightmanifold with an interior cavity for receiving thereinto liquid to betransferred from a subject to a plurality of waste-receiving containers;means connecting the interior cavity of said manifold to a plurality ofelongated tubular conduits through which liquid may be selectivelycaused to be passed; each tubular conduit having one end opening to saidinterior cavity of the manifold and the other end positioned outside themanifold; one tubular conduit being provided on the upper wall of themanifold to serve as an inlet to the manifold; other tubular conduitseach serving as a waste channel conduit, through which contaminatedwaste liquid may be selectively caused to flow by gravity outwardly fromand below the interior cavity of the manifold; a discardablewaste-receiving container connected to each such waste channel conduitat a point outwardly of the manifold; and a selectively manipulablevalve operatively associated with each waste channel conduit, andlocated in said conduit outwardly of the manifold and between themanifold and the discardable container, the valve being adapted to beselectively manipulated to either permit liquid flow from the manifoldto the container, or to isolate the contents of the waste-containingcontainer from the interior cavity of the manifold.
 3. A device as inclaim 2 wherein the entire construction, including the manifold, theplurality of conduits, and each discardable container and its associatedvalve, form a single sealed unit that is, prior to usage, assembledunder standard clean room conditions and is sterilized prior to use. 4.A device as in claim 2 wherein a portion of the conduit that extendsbetween each valve and its associated waste-receiving container iscapable of being severed, whereby after said container has been at leastpartially filled with waste liquid, and the valve has then beenselectively manipulated to isolate the container from the manifold, theseverable portion of the conduit is severed to permit removal of thefilled container for examination or discarding, leaving the closed valveattached to the manifold to serve as a barrier to exposing the manifold,its contents, and the subject to air-borne infection that could betransmitted through the manifold device.
 5. A device as in claim 2wherein at least one tubular conduit serves as an inlet for receivingliquid and passing same to the interior cavity of the manifold, and eachsuch tubular conduit inlet being provided with a selectively appliableclosure means to prevent exposing the interior cavity of the manifold toair-borne contamination.
 6. A device as in claim 2 wherein each of thediscardable waste-receiving containers is formed of a thin, flexiblematerial, such that each of said containers is collapsible for compactstorage adjacent the manifold prior to use.
 7. A device as in claim 2wherein the total capacity of all waste-receiving containers connectedto the manifold is greater than the total volume of liquid to beaccepted into the interior cavity of the manifold means.
 8. A device asin claim 2 wherein the manifold is preformed of plastic and is anelongated body, with means for selectively securing together the ends ofthe manifold to provide a member that encircles a portion of the body ofthe subject; and support means adapted to be worn by a subject andadapted to be secured to the manifold member for supporting the manifoldmember at a body encircling attitude.
 9. A device as in claim 2 whereina plurality of tubular inlet conduits are provided that each serve as aninlet for selective introduction therethrough of liquid into theinterior cavity of the manifold.
 10. A device as in claim 9 wherein eachof the tubular inlet conduits has operatively associated therewith aselectively operable closure means moveable between inlet-open andinlet-closed positions.
 11. A device as in claim 2 wherein the manifoldis laterally elongated and constructed to provide spaced upper and lowerelongated edges, there being at least one elongated tubular entryconduit, through the upper elongated edge of the manifold, through whichliquid is drained into the interior cavity of the manifold, and therebeing a selectively operable closure associated with each entry conduitfor selective movement between positions where the entry conduit isselectively opened or closed; there being a plurality of elongateddischarge conduits connected through the lower elongated edge of themanifold, and extending therebelow, and each discharge conduit beingconnected at its lower end to a discardable waste-receiving container,and the aggregate volume of the waste-receiving containers being greaterthan the volume of the manifold.
 12. A device as in claim 11 wherein themanifold is flexible to the extent permitting said manifold to be bentin an arcuate form to at least partially embrace a portion of the bodyof a human subject.
 13. A device as in claim 11 wherein the elongatedmanifold is a part of a flexible elongated member having overlappingends that are provided with fastening means thereon, to accommodate thedevice to body portions of different sizes.